FDA approves drug to prevent HIV infection

The federal government has approved for the first time a drug that can prevent an HIV infection, a significant development for Baltimore where transmission rates for the virus remain high and growing.

The U.S. Food and Drug Administration approved Truvada in 2004 to treat HIV, but on Monday said it can also be used to increase the odds of stopping the disease from taking hold in high-risk people such as gay men, IV drug users and sex workers

"Today's approval marks an important milestone in our fight against HIV," said Dr. Margaret A. Hamburg, FDA commissioner, in a statement. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."

The FDA stressed that to be most effective, the drug, manufactured by the California company Gilead Sciences, should be used in combination with other prevention methods such as testing, counseling and condom use.

Truvada is a combination of two antiretroviral medications that is now given with a third drug to treat the virus. It can have negative effects on bones and kidneys, and can worsen hepatitis B infections, and won't likely be prescribed widely as a preventive measure.

Two large clinical trials showed the drug reduced the risk of HIV infection by 42 percent in gay and bisexual men and transgender women, and by 75 percent in heterosexual couples where one partner was positive. Some experts say some study participants did not take the drug as directed and the prevention rates would be higher if they had.

Government data show that about 1.2 million Americans are living with HIV, though the rate of infection has remained stable since 2004.

Baltimore has one of the highest rates of infection in the nation, and officials declared HIV/AIDS a public health emergency in 2002. Still, the numbers continue to tick up in the city. The city reported just more than 13,000 residents living with HIV/AIDS at the end of 2009, the latest year available.

City health officials recently took the position to focus on HIV and sexually transmitted diseases, after a task force laid out a plan to cut infections by a quarter by 2015.

The city receives about $6 million to $7 million a year in public funds for outreach and education and about $20 million for treatment. Officials have been aggressive in targeting at-risk groups for testing and treatment, launching an advertising blitz to encourage people to know their HIV status.

And preventing more people from contracting HIV is the goal, said Dr. Joel Gallant, an infectious-disease specialist and AIDS expert at Johns Hopkins Hospital.

"This is a very big step forward," he said about the drug. "For the first time, we will be able to offer a preventive drug to HIV-negative people."

It remains to be seen who gets the drug because it's likely to be expensive, he said. The cost isn't known, but it could be $7,000 to $12,000 annually per person for the daily medication, and it would not be cost-effective to hand it out to everyone.

Unlike those who are HIV-positive who have access to federal funds for treatment, not everyone is likely to be covered for preventive medications. Those with insurance or Medicaid would likely have access to Truvada, but many of the most at-risk — specifically African- American men in Baltimore who have sex with men — do not have insurance and do not even have a regular doctor, said Gallant, a professor at the Hopkins School of Medicine and the associate director of the AIDS Service at Hopkins Hospital.

Also, redirecting funds away from testing and treatment for prevention could have dire consequences. Those who are infected would continue to infect other people, Gallant said. About 20 percent of those infected don't know their status, he said.

"Preventing HIV transition is the top priority," he said. "We need figure out the economics of this and try and do it without defunding treatment."